Clinical Study of the Effect of Gestational Weight Gain on Composition of Gut Microbiome
试验速览
- 阶段
- 不适用
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- gut microbiota infants
研究概览
简要总结
A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.
详细描述
Purpose To evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics.
Methods and analysis This is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from PUMCH and other 3 hospitals in Beijing. After signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. The blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. The infants' fecal samples will be collected at 0~3, 14, 42 days and 3, 6, 9, 12 months after born. Questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. Bio-specimen will be tested by 16S rRNA gene sequencing. Logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ensure a regular prenatal check in the clinical centers.
- •20-45 years old.
- •8-13 gestational weeks.
- •Singleton.
- •Fully understand and voluntarily sign the informed consent.
排除标准
- •IUI or IVF-ET pregnancy.
- •Smoking or drinking.
- •Antibiotics exposure within a month.
- •With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
- •With digestive disease, uncontrolled thyroid disease.
结局指标
主要结局
gut microbiota infants
时间窗: From delivery to 1 year postpartum.
The outcome will be measured at seven specific time points after the babies delivered.
maternal gut microbiota, vaginal microbiota, oral microbiota
时间窗: From enrollment to 42 days postpartum
The outcome will be measured at first, second and third trimester, as well as 42 days postpartum.
次要结局
未报告次要终点
研究者
Liangkun Ma
Deputy professor of obstetrics and gynecology
Peking Union Medical College Hospital